A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
Completed · Phase 3
Conditions studied: Dravet Syndrome, Lennox Gastaut Syndrome, Epileptic Encephalopathy
In brief
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
Key facts
- Study ID
- NCT03936777
- Run by
- Zogenix, Inc.
- People needed
- 412
- Starts
- 2019-04-22
- Expected to finish
- 2025-05-08
- Last updated by the study team
- 2025-11-17
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or nonpregnant, nonlactating female
- Satisfactory completion of a core study
- Has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another Zogenix-sponsored clinical trials with ZX008
- Subject's caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability
You may not qualify if…
- Current cardiac valvulopathy or pulmonary hypertension that is clinically significant
- Moderate or severe hepatic impairment
- Receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008
Where it is running
- Ep0215 144 — Los Angeles, California, United States
- Ep0215 108 — San Diego, California, United States
- Ep0215 101 — San Francisco, California, United States
- Ep0215 103 — Aurora, Colorado, United States
- Ep0215 115 — Gulf Breeze, Florida, United States
- Ep0215 104 — Miami, Florida, United States
- Ep0215 141 — Orlando, Florida, United States
- Ep0215 121 — Winter Park, Florida, United States
- Ep0215 117 — Atlanta, Georgia, United States
- Ep0215 110 — Chicago, Illinois, United States
- Ep0215 140 — Bethesda, Maryland, United States
- Ep0215 112 — Boston, Massachusetts, United States
- Ep0215 109 — Rochester, Minnesota, United States
- Ep0215 132 — Roseville, Minnesota, United States
- Ep0215 105 — Hackensack, New Jersey, United States
- Ep0215 118 — Livingston, New Jersey, United States
- Ep0215 150 — Hawthorne, New York, United States
- Ep0215 142 — New York, New York, United States
- Ep0215 131 — Cleveland, Ohio, United States
- Ep0215 124 — Memphis, Tennessee, United States
- Ep0215 146 — Dallas, Texas, United States
- Ep0215 126 — Fort Worth, Texas, United States
- Ep0215 106 — Salt Lake City, Utah, United States
- Ep0215 119 — Seattle, Washington, United States
- Ep0215 107 — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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